On Emergent OTC Naloxone Switch, Tight Timeline For FDA Decision Following Advisory Committee
NDAC, AADPAC Meeting 15 February, PDUFDA Date 29 March For Emergent’s Proposal
Executive Summary
Priority review pushes up to 29 March FDA’s deadline for decision on Emergent’s sNDA for OTC Narcan nasal spray. Agency schedules joint advisory committee on proposal for 15 February.
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Urgency For Approval Of OTC Naloxone In US Weighed Against Using Untested Package Labeling
All members of a joint advisory panel noted an urgent need to expand naloxone access and voted yes on OTC sales of Emergent's Narcan nasal spray, but many also raised concerns about the testing needed for the DFl Facts label the firm unveiled during the meeting.
Urgency For Approval Of OTC Naloxone In US Weighed Against Using Untested Package Labeling
All members of joint advisory panel noted urgent need to expand access to naloxone and voted yes on OTC sales of Emergent's Narcan nasal spray, but many also pointed out concerns for testing needed for DFl Facts label firm unveiled to the panel as well as to FDA officials during meeting.
OTC Naloxone In US Could Limit Access Due To Costs, Comments On Emergent Switch NDA Argue
The American Society of Anesthesiologists and attorney Scott Lassman disagree with the FDA's suggestion that studies showing all naloxone products can be used safely over the counter indicates all of them can be moved to nonprescription status. Both were included in comments submitted ahead of the agency's Nonprescription Drug and Anesthetic and Analgesic Drug Products advisory committee meeting on the subject.